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Completed

NCT Number: NCT05083299

Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate

The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BuKyung Kim

Busan, 49267, South Korea

About this study

The purpose of this study is to evaluate the effect of Anple-one SR Tablet on the improvement of symptoms in daily care environments within the scope of 300 milligrams of Anpl-one SR Tablet (sarpogrelate hydrochloride agent) using PAQ.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults over 19 and under 80 years of age.
  • Patients who first administered Sarpogrelate hydrochloride drugs or less than 3 months to improve ischemic symptoms such as ulcers, pain, and coldness caused by chronic arterial obstruction (Burger's disease, obstructive arteriosclerosis, diabetic peripheral angiopathy, etc.).
  • Patient who voluntarily signed a written consent form approved by the Clinical Trial Review Committee or Ethics Committee and agreed to participate in the study by the patient or the subject's agent.

Exclusion criteria

  • Patient who is expected to have less than two years of life expectancy.
  • Patient who have bleeding within a week of participation in the study
  • Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.).
  • A female patient who is likely to be pregnant or pregnant.
  • Female patients who are lactating or are scheduled to be lactated at the time of participation in the study.
  • Patients with severe renal disease and liver disease.

Treatment and study plan

Sarpogrelate

Drug

Anpl-one SR

Other names: Anpl-one SR

Primary outcomes

  1. Change in Peripheral Artery Questionnaire

    Time frame: 24 weeks

    Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline

Secondary outcomes

  1. Peripheral Artery Questionnaire change

    Time frame: 12 weeks

    Peripheral Artery Questionnaire change at 12 weeks compared to baseline

  2. Peripheral Artery Questionnaire change

    Time frame: 24 weeks

    Peripheral Artery Questionnaire change at 24 weeks compared to baseline

  3. Change in each domain of Peripheral Artery Questionnaire

    Time frame: 24 weeks

    Change in each domain of Peripheral Artery Questionnaire at 24 weeks compared to baseline

  4. Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients

    Time frame: 12 weeks

    Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 12 weeks

  5. Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients

    Time frame: 24 weeks

    Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 24 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate on Symptom Improvement in Patients With Peripheral Arterial Disease

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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